The government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India during the same time that trials of the same phase are being conducted in other countries. But even under the new rule, phase 1 trials will not normally be permitted in India. The old rule was designed to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin.
The change was made in response to vociferous demands from multinational drug companies and in the light of WTO agreement where India is playing a major role as a stakeholder. In recent timesit has become increasingly difficult to test drugs in Western countries, with their strict regulations, elaborate safety and compensation requirements, and small populations, all of which make the recruitment of research subjects slow and expensive. The move is made to outsource some of their trials to Third World countries such as China, Indonesia, Thailand, and India.